A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of MDR-001 Administered Orally Over 52 Weeks in Participants With Overweight or Obesity (MOBILE)
1 other identifier
interventional
738
1 country
45
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy and safety of the oral small molecule MDR-001 Tablets over 52 weeks as an adjunct to a lifestyle intervention in participants with overweight or obesity.The goal of this clinical trial is to determine whether the oral drug MDR-001 can improve weight management in adult participants with overweight or obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedFirst Posted
Study publicly available on registry
December 10, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
December 22, 2025
November 1, 2025
1.3 years
November 18, 2025
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage change from baseline in body weight (%) at Week 52
(Week 52 body weight-baseline body weight)/baseline weight
baseline,Week 52
Percentage (%) of participants who achieve≥5% body weight reduction from baseline at Week 52
(Week 52 body weight-baseline body weight)/baseline body weight, who achieve≥5%
baseline,Week 52
Secondary Outcomes (17)
Change from baseline in body weight (kg) at Week 52
baseline,Week 52
Percentage (%) of participants who achieve ≥ 10% or ≥ 15% body weight reduction from baseline at Week 52
Baseline,Week52
Change from baseline in BMI (kg/m2) at Week 52
Baseline,Week52
Change from baseline in waist circumference (cm) at Week 52
Baseline, Week52
Change from baseline in hip circumference (cm) at Week 52
Baseline,Week 52
- +12 more secondary outcomes
Study Arms (3)
MDR-001 Dose 1
EXPERIMENTALMDR-001 Dose 2
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Have given written informed consent to participate in this study
- Chinese male or female participants who are aged 18-65 (inclusive) years at the time of signing the ICF
- Participants who are obesity (BMI ≥ 28.0 kg/m2), or overweight (24.0 kg/m2 ≤ BMI \< 28.0 kg/m2) with at least one of the the following weight-related comorbidities at screening:1) Pre-diabetes. 2) Hypertension.3) Dyslipidemia.4) Fatty liver.5) Obstructive sleep apnea syndrome.6) Complaint of weight-bearing joint pain.
- Participants had a stable weight maintenance during the 3 months of dietary and physical activity prior to screening (participant-reported data acceptable) and no more than 5% weight fluctuation
You may not qualify if:
- Obesity induced by secondary diseases or drug
- Have diabetes mellitus
- Have any lifetime history of a suicidal attempt or suicidal behavior
- Have a history of depressive disorder
- History of gout within 6 months prior to screening
- History of major cardiovascular or cerebrovascular disease within 6 months prior to screening, defined as:1)Acute myocardial infarction (MI), percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), heart valve repair/replacement, unstable angina, hemorrhagic stroke (stroke), ischemic stroke (including transient ischemic attack \[TIA\]).2)Congestive heart failure of New York Heart Association (NYHA) class III or IV.3)Severe arrhythmias
- History of malignancy within 5 years prior to screening or newly diagnosed malignancy at screening
- Have a family or personal history (parents, children, and siblings of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2 .
- Abnormal thyroid function tests at screening not adequately controlled by stable medication doses , or thyroid ultrasound at screening showing thyroid nodules classified as Chinese-thyroid imaging-reporting and data system category 4 or higher.
- History of significant gastrointestinal disease or gastrointestinal surgery or clinically significant gastric emptying abnormality within 6 months prior to screening.
- History of intestinal disorders deemed clinically significant by the investigator, or acute hemorrhoidal episode within 3 months prior to screening.
- History of acute or chronic pancreatitis, or abnormally elevated serum amylase or lipase levels at screening.
- revious acute or chronic hepatitis, or symptoms and signs of any other liver disease other than non-alcoholic fatty liver disease, or abnormalities in related laboratory tests at screening
- Presence of acute or chronic cholecystitis at screening, or symptomatic or treatment-requiring cholelithiasis/gallbladder polyps at screening, or newly diagnosed cholelithiasis within 6 months before screening
- Hypersensitivity or suspected hypersensitivity to glucagon-like peptide 1 receptor agonist (GLP-1RA) drugs or excipients.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MindRank AI Ltdlead
Study Sites (45)
Peking University People's Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Changde City
Changde, China
People's Hospital of Hunan Province
Changsha, China
The Fourth Hospital of Changsha
Changsha, China
The Third People's Hospital of Datong
Datong, China
Dongyang People's Hospital
Dongyang, China
Ganzhou People's Hospital
Ganzhou, China
The Second Hospital of Anhui Medical University
Hefei, China
The SecondPeople's Hospital of Hefei
Hefei, China
Huizhou Central People's Hospital
Huizhou, China
Huizhou Third People's Hospital
Huizhou, China
Huzhou Central Hospital
Huzhou, China
Central Hospital Affiliated To Shangdong First Medical University
Jinan, China
Central Hospital of Jin zhou
Jinzhou, China
Jingzhou Hospital Affiliated to Yangtze University
Jinzhou, China
The Third Affiliated Hospital of Jinzhou Medical University
Jinzhou, China
JiuJiang No.1 people's Hospital
Jiujiang, China
Lianyungang Hospital of TCM
Lianyungang, China
Liaocheng People's Hospital
Liaocheng, China
Loudi Central Hospital
Loudi, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
Pingxiang People's Hospital
Pingxiang, China
Sanya Central Hospital (Hainan Third People's Hospital)
Sanya, China
Shenyang Fifth People Hospital
Shenyang, China
Shenyang Sixth People's Hospital
Shenyang, China
The People's Hospital of liaoning Province
Shenyang, China
The Second Hospital of Hebei Medical University
Shijia Zhuang, China
Siping Central People's Hospital
Siping, China
The First Affiliated Hospital of Soochow University
Suzhou, China
First Hospital of Shanxi Medical University
Taiyuan, China
Shanxi Bethune Hospital
Taiyuan, China
Taizhou Hospital of Zhejiang province
Taizhou, China
Wuhan Third Hospital•Tongren Hospital of Wuhan University
Wuhan, China
Xuancheng People's Hospital
Xuancheng, China
Yichang Central People's Hospital
Yibin, China
Yichang Central People's Hospital
Yichang, China
Yueyang Central Hospital
Yueyang, China
Yueyang People's Hospital
Yueyang, China
The Second Affiliated Hospital of ZhengzhouUniversity
Zhengzhou, China
The Third People's Hospital of Zhengzhou
Zhengzhou, China
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, China
PKUCare Luzhong Hospital
Zibo, China
Zibo Central Hospital
Zibo, China
Zibo Municipal Hospital
Zibo, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2025
First Posted
December 10, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
December 22, 2025
Record last verified: 2025-11